Tivicay

"The number of pregnant and breastfeeding women in Malawi with HIV who started life-saving antiretroviral treatment increased by more than 700 percent in one year, according to a study in CDC's Morbidity and Mortality Weekly Report. The "...

Tivicay

PATIENT INFORMATION

TIVICAY®
(TIV-eh-kay)
(dolutegravir) Tablets

Read this Patient Information before you start taking
TIVICAY and each time you get a refill. There may be new information. This
information does not take the place of talking with your healthcare provider
about your medical condition or treatment.

It is not known if TIVICAY is safe and effective in
children under 12 years of age or who weigh less than 88 pounds.

When used with other HIV-1 medicines to treat HIV-1
infection, TIVICAY may help:

reduce the amount of HIV-1 in your blood. This is called
“viral load”.

increase the number of white blood cells called CD4+ (T)
cells in your blood, which help fight off other infections.

Reducing the amount of HIV-1 and increasing the CD4+ (T)
cells in your blood may help improve your immune system. This may reduce your
risk of death or getting infections that can happen when your immune system is
weak (opportunistic infections).

TIVICAY does not cure HIV-1 infection or AIDS. You
must stay on continuous HIV-1 therapy to control HIV-1 infection and decrease
HIV-related illnesses.

Avoid doing things that can spread HIV-1 infection to
others.

Do not share or re-use needles or other injection
equipment.

Do not share personal items that can have blood or body
fluids on them, like toothbrushes and razor blades.

Do not have any kind of sex without protection. Always
practice safer sex by using a latex or polyurethane condom to lower the chance
of sexual contact with any body fluids such as semen, vaginal secretions, or
blood.

Ask your healthcare provider if you have any questions
about how to prevent passing HIV to other people.

Who should not take TIVICAY?

Do not take TIVICAY if you:

have ever had an allergic reaction to a medicine that
contains dolutegravir (TIVICAY, TRIUMEQ)

take dofetilide (TIKOSYN®). Taking TIVICAY and
dofetilide (TIKOSYN) can cause side effects that may be life-threatening.

are pregnant or plan to become pregnant. It is not known
if TIVICAY will harm your unborn baby. Tell your healthcare provider if you
become pregnant while taking TIVICAY. Pregnancy Registry. There is a pregnancy registry for women who take
antiviral medicines during pregnancy. The purpose of the registry is to collect
information about the health of you and your baby. Talk to your healthcare
provider about how you can take part in this registry.

are breastfeeding or plan to breastfeed. Do not
breastfeed if you take TIVICAY.

You should not breastfeed if you have HIV-1 because of
the risk of passing HIV-1 to your baby.

It is not known if TIVICAY passes into your breast milk.

Talk to your healthcare provider about the best way to
feed your baby.

Tell your healthcare provider about the medicines you
take, including prescription and over-the-counter medicines, vitamins, or
herbal supplements.

TIVICAY and other medicines may affect each other causing
side effects. TIVICAY may affect the way other medicines work, and other
medicines may affect how TIVICAY works.

antacids, laxatives or other medicines that contain
aluminum, magnesium, sucralfate (CARAFATE®), or buffered medicines.
TIVICAY should be taken at least 2 hours before or 6 hours after you take these
medicines.

iron or calcium supplements. Supplements including
multivitamins containing calcium or iron may be taken at the same time with
TIVICAY if taken with food. Otherwise, TIVICAY should be taken at least 2 hours
before or 6 hours after you take these medicines.

Ask your healthcare provider or pharmacist if you are not
sure if your medicine is one that is listed above.

Know the medicines you take. Keep a list of them to show
your healthcare provider and pharmacist when you get a new medicine.

How should I take TIVICAY?

Take TIVICAY exactly as your healthcare provider tells
you.

Do not change your dose or stop taking TIVICAY without
talking with your healthcare provider.

Stay under the care of a healthcare provider while taking
TIVICAY.

You can take TIVICAY with or without food.

If you miss a dose of TIVICAY, take it as soon as you
remember. If it is within 4 hours of your next dose, skip the missed dose and
take the next dose at your regular time. Do not take 2 doses at the same time.
If you are not sure about your dosing, call your healthcare provider.

Do not run out of TIVICAY. The virus in your blood may
become resistant to other HIV-1 medicines if TIVICAY is stopped for even a
short time. When your supply starts to run low, get more from your healthcare
provider or pharmacy.

If you take too much TIVICAY, call your healthcare
provider or go to the nearest hospital emergency room right away.

What are the possible side effects of TIVICAY?

TIVICAY may cause serious side effects, including:

Allergic reactions. Call your healthcare provider
right away if you develop a rash with TIVICAY. Stop taking TIVICAY and get
medical help right away if you:

develop a rash with any of the following signs or
symptoms

fever

generally ill feeling

extreme tiredness

muscle or joint aches

blisters or sores in mouth

blisters or peeling of the skin

redness or swelling of the eyes

swelling of the mouth, face, lips, or tongue

problems breathing

develop any of the following signs or symptoms of
liver problems:

yellowing of the skin or whites of the eyes

dark or tea-colored urine

pale-colored stools or bowel movements

nausea or vomiting

loss of appetite

pain, aching, or tenderness on the right side below the
ribs

Changes in liver tests. People with a
history of hepatitis B or C virus may have an increased risk of developing new
or worsening changes in certain liver tests during treatment with TIVICAY. Your
healthcare provider may do tests to check your liver function before and during
treatment with TIVICAY.

Changes in body fat can happen in people who
take HIV-1 medicines. These changes may include increased amount of fat in
the upper back and neck (“buffalo hump”), breast, and around the middle of your
body (trunk). Loss of fat from the legs, arms, and face may also happen. The
exact cause and long-term health effects of these problems are not known.

Changes in your immune system (Immune Reconstitution
Syndrome) can happen when you start taking HIV-1 medicines. Your immune
system may get stronger and begin to fight infections that have been hidden in
your body for a long time. Tell your healthcare provider right away if you
start having new symptoms after starting your HIV-1 medicine.

The most common side effects of TIVICAY include:

see “Allergic reactions” above

trouble sleeping

tiredness

headache

Tell your healthcare provider about any side effect that
bothers you or that does not go away.

These are not all the possible side effects of TIVICAY.
For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects.
You may report side effects to FDA at 1-800-FDA-1088.

How should I store TIVICAY?

Store TIVICAY at room temperature between 68°F to 77°F
(20°C to 25°C).

Keep TIVICAY and all medicines out of the reach of
children.

General information about the safe and effective use
of TIVICAY.

Medicines are sometimes prescribed for purposes other
than those listed in a Patient Information leaflet. Do not use TIVICAY for a
condition for which it was not prescribed. Do not give TIVICAY to other people,
even if they have the same symptoms you have. It may harm them.

You can ask your pharmacist or healthcare provider for
information about TIVICAY that is written for health professionals.